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Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy

Primary Purpose

Nausea, Vomiting

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activated Nometex Device
Unactivated Nometex Device
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer
  2. Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion
  3. 18 years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center
  4. ECOG Status of 0-2
  5. Standardized Antiemetic Regimen

Exclusion Criteria:

  1. Pre-existing or at-risk for a peripheral neuropathy in region of device placement
  2. Implanted cardiac pace maker
  3. Nickel or other metal allergies
  4. Previous experience with median nerve/P6 stimulation
  5. Receiving concurrent radiation therapy
  6. Previous participants of this study will be excluded from future participation in this study.

Sites / Locations

  • Helen F. Graham Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Activated Nometex Device

Unactivated Nometex Device

Arm Description

Nometex Device that is activated so will be sending electrical pulses to the median nerve which will travel through afferent nerve fibers to the emetic centers of the brain. It is in these areas that the neurotransmitters modulate signals going to the stomach via the Vagus nerve. These electrical signals normalize the stomach rhythms, thereby alleviating nausea and vomiting.

The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy.

Outcomes

Primary Outcome Measures

Number of episodes of Vomiting
The primary outcome measure we are looking for is the number of vomiting episodes in patients with active wrist bands verse the sham wrist bands.
Severity of Nausea
One of the primary outcomes we are investigating is the severity of nausea in patients with active wrist bands verse the sham wrist bands.

Secondary Outcome Measures

Acute Emetic Episodes
More specifically, the number of episodes of vomiting on Day 1.
Severity of nausea
The severity of acute nausea on day 1 of treatment.
Delayed severe nausea
The delayed number severe nausea episodes on days 2-5.
Delayed emetic episodes
Looking at the number of delayed emetic episodes during days 2-5 of treatment.
Rescue Medication Use
Will look at the use of rescue medication throughout treatment.

Full Information

First Posted
October 14, 2013
Last Updated
September 30, 2015
Sponsor
Christiana Care Health Services
Collaborators
Neurowave Medical Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT01980160
Brief Title
Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy
Official Title
Randomized Single-Blind Study of Nometex as an Adjunct to Standard Anti-emetics in Ovarian and Advanced Endometrial and Cervical Cancer Patients Who Receive Moderately to Highly Emetogenic Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Did not receive IRB approval from our institution therefore the study was closed.
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services
Collaborators
Neurowave Medical Technologies

4. Oversight

5. Study Description

Brief Summary
The primary study hypotheses are that, without increasing doses of breakthrough medications or device intolerance, the Nometex™ device worn for 5-days beginning with the day of chemotherapy administration in women with ovarian or advanced endometrial or cervical cancer will, as an adjunct to standard-of-care anti-emetics, reduce vomiting episodes, and reduce the severity of nausea. The secondary hypotheses are that the Nometex™ device reduces acute (Day 1) emetic episodes, day 1 and days 2-5 severity of nausea, and delayed (days 2-5) emetic episodes without increasing doses of breakthrough medications or device intolerance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activated Nometex Device
Arm Type
Active Comparator
Arm Description
Nometex Device that is activated so will be sending electrical pulses to the median nerve which will travel through afferent nerve fibers to the emetic centers of the brain. It is in these areas that the neurotransmitters modulate signals going to the stomach via the Vagus nerve. These electrical signals normalize the stomach rhythms, thereby alleviating nausea and vomiting.
Arm Title
Unactivated Nometex Device
Arm Type
Sham Comparator
Arm Description
The Nometex device will not be activated and therefore have no effect on the nausea/vomiting associated with chemotherapy.
Intervention Type
Device
Intervention Name(s)
Activated Nometex Device
Intervention Description
Nometex Device that is activated so will be sending electrical pulses to the median nerve which will travel through afferent nerve fibers to the emetic centers of the brain. It is in these areas that the neurotransmitters modulate signals going to the stomach via the Vagus nerve. These electrical signals normalize the stomach rhythms, thereby alleviating nausea and vomiting.
Intervention Type
Device
Intervention Name(s)
Unactivated Nometex Device
Other Intervention Name(s)
Patients using this device will be given an unactivated Nometex device. It should be the same in appearance as the activated device.
Primary Outcome Measure Information:
Title
Number of episodes of Vomiting
Description
The primary outcome measure we are looking for is the number of vomiting episodes in patients with active wrist bands verse the sham wrist bands.
Time Frame
1 month
Title
Severity of Nausea
Description
One of the primary outcomes we are investigating is the severity of nausea in patients with active wrist bands verse the sham wrist bands.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Acute Emetic Episodes
Description
More specifically, the number of episodes of vomiting on Day 1.
Time Frame
1 day
Title
Severity of nausea
Description
The severity of acute nausea on day 1 of treatment.
Time Frame
1 day
Title
Delayed severe nausea
Description
The delayed number severe nausea episodes on days 2-5.
Time Frame
5 days
Title
Delayed emetic episodes
Description
Looking at the number of delayed emetic episodes during days 2-5 of treatment.
Time Frame
5 days
Title
Rescue Medication Use
Description
Will look at the use of rescue medication throughout treatment.
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with ovarian (including fallopian tube) or advanced endometrial or cervical cancer Chemotherapy-naïve or who have had previous chemotherapy exposure, but who have not yet received the first infusion 18 years of age or older, and can provide cognizant informed consent presenting to the Helen F. Graham Cancer Center ECOG Status of 0-2 Standardized Antiemetic Regimen Exclusion Criteria: Pre-existing or at-risk for a peripheral neuropathy in region of device placement Implanted cardiac pace maker Nickel or other metal allergies Previous experience with median nerve/P6 stimulation Receiving concurrent radiation therapy Previous participants of this study will be excluded from future participation in this study.
Facility Information:
Facility Name
Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

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Relief Band as an Adjunct to Antiemetic Therapy in Patients Who Receive Mod to Highly Emetogenic Chemotherapy

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